StenosisAVeVANCT02790606
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in AV Graft Patients (AVeVA)
A study testing Covera(TM) Vascular Covered Stent in people with Stenosis and Restenosis, run by C. R. Bard at 16 sites in United States.
Trial summary
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stenosis, Restenosis
- What is being tested?
- Covera(TM) Vascular Covered Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 16 sitesUnited States
- Study dates
- Jul 2016to 16 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Clinical Inclusion Criteria:
- Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
- Subject must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
- Subject must be willing to comply with the protocol requirements, including clinical and telephone follow-up.
- Subject must have a synthetic AV access graft located in an arm that has been implanted for ≥ 30 days and must have undergone at least one successful dialysis session prior to the index procedure.
Angiographic Inclusion Criteria
- Subject must have angiographic evidence of a stenosis ≥ 50% (by visual estimation) located at the graft-vein anastomosis of the subject's synthetic AV access graft and present with clinical evidence of graft dysfunction at the synthetic AV graft-vein anastomosis.
- The target lesion must be ≤ 9cm in length. Note: multiple stenoses may exist within the target lesion.
- The reference vessel diameter of the adjacent non-stenotic vessel must be between 5.0 and 9.0mm.
Clinical Exclusion Criteria:
- The subject is dialyzing with an AV fistula.
- The hemodialysis access is located in the lower extremity.
- The subject has an infected AV access graft or uncontrolled systemic infection.
- The subject has a known uncontrolled blood coagulation/bleeding disorder.
- The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
- The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum.
- The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
- The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.
Angiographic Exclusion Criteria:
- Additional stenotic lesions (≥ 50%) in the venous outflow that are > 3cm from the edge of the target lesion and are not successfully treated (defined as < 30% residual stenosis) prior to treating the target lesion.
- An aneurysm or pseudoaneurysm is present within the target lesion.
- The location of the target lesion would require the COVERA™ Vascular Covered Stent be deployed across the elbow joint.
- The target lesion is located within a stent or stent graft.
- The location of the target lesion would require that the COVERA™ Vascular Covered Stent be placed in the central veins (subclavian, brachiocephalic, Superior Vena Cava (SVC)) or under the clavicle at the thoracic outlet.
- There is incomplete expansion of an appropriately-sized angioplasty balloon to its expected profile, in the operator's judgment, during primary angioplasty at the target lesion prior to implantation of the study device.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Surgical Specialists of Charlotte
Charlotte, North Carolina, 28207
Chicago Access Care
Chicago, Illinois, 60521
Tarrant Vascular Clinic
Fort Worth, Texas, 76104
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32207
Ocala Kidney Group
Ocala, Florida, 34471
St. Joseph Hospital
Orange, California, 92868
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, 85012
Providence Access Care
Providence, Rhode Island, 02906
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
NC Nephrology
Raleigh, North Carolina, 27610
Capital Nephrology Access Center
Sacramento, California, 95815
Clinical Advancement Center, PLLC
San Antonio, Texas, 78215
Southwest Vascular Center
Tempe, Arizona, 85281
Arizona Kidney Disease and Hypertension Center Medical Research Services, LLC
Tucson, Arizona, 85712
Renal and Transplant Associates of New England, P.C.
West Springfield, Massachusetts, 01089
The Cardiovascular Care Group
Westfield, New Jersey, 07090
About this study
Official title: Prospective, Multi-Center Clinical Study of the Bard® COVERA™ Arteriovenous (AV) Stent Graft in the Treatment of Stenosis at the Graft-Vein Anastomosis of AV Graft Circuits (AVeVA)
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
Read the detailed description
This study will compare the use of the COVERA™ Vascular Covered Stent (following percutaneous transluminal angioplasty (PTA)) to safety and effectiveness performance goals (PGs) for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of subjects dialyzing with an AV graft.
- Conditions
- Stenosis, Restenosis
- Being tested
- Covera(TM) Vascular Covered Stent
- Keywords
- ESRD, Stenosis, Restenosis, Hemodialysis, AV Graft
- Medical subject headings
- Constriction, Pathologic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covera(TM) Vascular Covered StentDevice
Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
| Study group | Role | What they receive |
|---|---|---|
| Covera(TM) Vascular Covered Stent | Experimental | Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Receives: Device: Covera(TM) Vascular Covered Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events
Safety is defined as freedom from any adverse event(s) (AEs), localized or systemic, that reasonably suggests the involvement of the AV access circuit (not including stenosis or thrombosis) that require or result in any of the following alone or in combination: additional interventions (including surgery); in-patient hospitalization or prolongation of an existing hospitalization; or death.
Measured: 30 days post index procedure
Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency
Target Lesion Primary Patency (TLPP) is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access.
Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV access graft due to inability to treat the original treatment area.
The primary effectiveness endpoint is evaluated against a performance goal (PG) of 40%.
Measured: 6 months post index procedure
Secondary outcomes (10)
Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP)
TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access.
Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV access graft due to inability to treat the original treatment area.
The 1, 3, 6, 12, 18 and 24 months final results are reported below.
Measured: 1, 3, 6, 12, 18 and 24 months post index procedure
Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP)
ACPP is defined as the interval following the index intervention until the next access thrombosis or repeated intervention.
ACPP ends with a reintervention anywhere within the access circuit. Vessel rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis.
The 1, 3, 6, 12, 18 and 24 months final results are reported below.
Measured: 1, 3, 6, 12, 18 and 24 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Device and Procedure Related AEs Involving the AV Access Circuit
Number of Participants with device and procedure related Adverse Events involving the AV access circuit.
The access circuit is the area from the arterial inflow to the SVC-right atrial junction.
The 1, 3, 6, 12, 18 and 24 months final results are reported below.
Measured: 1, 3, 6, 12, 18 and 24 months post index procedure,
Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions
Total Number of AV Access Circuit Reinterventions defined as the number of reinterventions to the AV access circuit until access abandonment or through study completion.
The 1, 3, 6, 12, 18 and 24 months final results are reported below.
Measured: 1, 3, 6, 12, 18 and 24 months post index procedure.
Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions
Total Number of Target Lesion Reinterventions defined as the number of reinterventions to maintain target lesion patency.
The 1, 3, 6, 12, 18 and 24 months final results are reported below.
Measured: 1, 3, 6, 12, 18 and 24 months post index procedure
Endpoint Without Hypothesis Testing: Index of Patency Function (IPF)
IPF is defined as the time from the index study procedure to study completion or access abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis.
The 1, 3, 6, 12, 18 and 24 months final results are reported below.
The IPF is representative of the number of days between interventions to maintain access circuit patency. The minimum and maximum ranges for the Index of Patency Function are as follows: 1 month (6.3 - 30.0); 3 months (6.3 - 90.0); 6 months (6.3 - 180.0); 12 months (6.3 - 365.0); 18 months (6.3 - 545.0); and 24 months (6.3 - 730.0). Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions.
Measured: 1, 3, 6, 12, 18 and 24 months post index procedure
Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T)
IPF-T (Index of Patency Function - Target Lesion) is defined as the time from the index study procedure to study completion or complete access abandonment divided by the number of visits for a reintervention performed at the target lesion in order to maintain vascular access for hemodialysis.
The 1, 3, 6, 12, 18 and 24 months final results are reported below.
The IPF for target lesion patency is representative of the approximate (mean) number of days between interventions to maintain target lesion patency. The minimum and maximum ranges for the Index of Patency Function are as follows: 1 month (6.3 - 30.0); 3 months (6.3 - 90.0); 6 months (6.3 - 180.0); 12 months (6.3 - 365.0); 18 months (6.3 - 545.0); and 24 months (6.3 - 730.0). Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions.
Measured: 1, 3, 6, 12, 18 and 24 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency
Secondary Patency is defined as the interval after the index intervention until the access is abandoned. Multiple repetitive treatments can be included in post-intervention secondary patency.
The 1, 3, 6, 12, 18 and 24 months final results are reported below.
Measured: 1, 3, 6, 12, 18 and 24 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Technical Success (for Stent Graft Placement)
Technical Success is defined as successful deployment, based on the operator's opinion, of the implant to the intended location assessed at the time of the index procedure.
Measured: At time of index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Procedure Success
Procedure Success is defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis.
Measured: At time of index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017
- Study completion16 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StenosisStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bart Dolmatch, M.D., Principal investigator, The Palo Alto Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790606
- Sponsor's protocol ID
- BPV-15-001
- Acronym
- AVeVA
- Status last verified
- Apr 2020
- First submitted
- 25 May 2016
- Last updated
- 14 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center Clinical Study of the Bard® COVERA™ Arteriovenous (AV) Stent Graft in the Treatment of Stenosis at the Graft-Vein Anastomosis of AV Graft Circuits (AVeVA)
- ClinicalTrials.gov ID
- NCT02790606
- Acronym / sponsor ID
- AVeVA / BPV-15-001
- Conditions
- Stenosis, Restenosis
- Keywords
- ESRD, Stenosis, Restenosis, Hemodialysis, AV Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- 16 Mar 2019 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Posted 26 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
Detailed description
This study will compare the use of the COVERA™ Vascular Covered Stent (following percutaneous transluminal angioplasty (PTA)) to safety and effectiveness performance goals (PGs) for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of subjects dialyzing with an AV graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covera(TM) Vascular Covered Stent | Experimental | Device: Covera(TM) Vascular Covered StentPlacement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covera(TM) Vascular Covered StentTreatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent. | Device | Covera(TM) Vascular Covered Stent |
Primary outcome
Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events
Time frame: 30 days post index procedure
Safety is defined as freedom from any adverse event(s) (AEs), localized or systemic, that reasonably suggests the involvement of the AV access circuit (not including stenosis or thrombosis) that require or result in any of the following alone or in combination: additional interventions (including surgery); in-patient hospitalization or prolongation of an existing hospitalization; or death.
Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency
Time frame: 6 months post index procedure
Target Lesion Primary Patency (TLPP) is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV access graft due to inability to treat the original treatment area. The primary effectiveness endpoint is evaluated against a performance goal (PG) of 40%.
10 secondary outcomes
Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP)
Time frame: 1, 3, 6, 12, 18 and 24 months post index procedure
Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP)
Time frame: 1, 3, 6, 12, 18 and 24 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Device and Procedure Related AEs Involving the AV Access Circuit
Time frame: 1, 3, 6, 12, 18 and 24 months post index procedure,
Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions
Time frame: 1, 3, 6, 12, 18 and 24 months post index procedure.
Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions
Time frame: 1, 3, 6, 12, 18 and 24 months post index procedure
Endpoint Without Hypothesis Testing: Index of Patency Function (IPF)
Time frame: 1, 3, 6, 12, 18 and 24 months post index procedure
Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T)
Time frame: 1, 3, 6, 12, 18 and 24 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency
Time frame: 1, 3, 6, 12, 18 and 24 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Technical Success (for Stent Graft Placement)
Time frame: At time of index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Procedure Success
Time frame: At time of index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Stenosis
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Dolmatch, M.D. principal investigator
The Palo Alto Medical Foundation
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Covera(TM) Vascular Covered Stent in people with Stenosis and Restenosis, run by C. R. Bard at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events (time frame: 30 days post index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.